ESSURE
Report
- Report Number
- 2951250-2017-08184
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- July 1, 2010
- Report Date
- March 21, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN ("PAIN IN SIDES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / PELVIC PAIN RIGHT SIDE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S)) "), EMBEDDED DEVICE ("LEFT DEVICE FOUND TO BE EMBEDDED IN THE UTERINE WALL") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT (GRAVIDA 8, PARA 4) WHO HAD ESSURE (BATCH NO. 832032) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE// FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S),". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 4 (B)(6) ECTOPIC PREGNANCY IN 2001, UMBILICAL CORD AROUND NECK AND MENARCHE (AT THE AGE OF 13). ETHNICITY- AFRICAN AMERICAN. CONCURRENT CONDITIONS INCLUDED ABORTION, OBESITY, HYPERTENSION, DEPRESSION, BACTERIAL VAGINOSIS, HEADACHE, NABOTHIAN CYST, VAGINAL DISCHARGE, INFECTION AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 AND NORETHISTERONE (MICRONOR) FROM (B)(6) 2009 FOR CONTRACEPTION AS WELL AS IRON, LABETALOL, METHYLDOPA, NIFEDIPINE (PROCARDIA XL) AND TRIAMTERENE. ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN IN SIDES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE), SURGERY (TO REMOVE THE ESSURE, BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED) AND SURGERY (BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD EMERGENCY C-SECTION DUE TO THE UMBILICAL CORD WRAPPED AROUND HIS NECK. TWO ABORTIONS AFTER ESSURE PLACEMENT. REMOVAL DETAILS:THE RIGHT ESSURE COIL WAS EMBEDDED IN THE RIGHT MYOMETRIUM JUST LATERAL TO THE RIGHT OSTIA. THIS WAS ALSO REMOVED HYSTEROSCOPICALLY. BOTH ESSURE COILS WERE REMOVED INTACT WITH NO PIECES LEFT BEHIND. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: RIGHT SIDE PAIN". CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED: LOT NUMBER ADDED.THE PREVIOUS EVENT ¿PREGNANCY/UNINTENDED PREGNANCY UPDATED TO ¿PREGNANCY/UNINTENDED PREGNANCY/ PREGNANCY (NO COMPLICATIONS). EVENTS PFS-PERFORATION (FALLOPIAN TUBE(S)), ADDED.EVENT FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S) CLUBBED WITH PREVIOUS EVENT DEVICE INEFFECTIVE. EVENT EMBEDDED DEVICE ADDED FROM MR.REPORTER INFORMATION, CONCOMITANT DISEASE, HISTORICAL CONDITION WERE ADDED. PREGNANCY OUTCOME WERE UPDATED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / PELVIC PAIN RIGHT SIDE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), EMBEDDED DEVICE ("LEFT DEVICE FOUND TO BE EMBEDDED IN THE UTERINE WALL"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 832032-INVALID, 632032) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE// FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S),". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6)1997,(B)(6)2002,(B)(6)2009,(B)(6)2015.), ECTOPIC PREGNANCY IN 2001, UMBILICAL CORD AROUND NECK, MENARCHE (AT THE AGE OF 13) AND PREGNANCY WITH CONTRACEPTIVE DEVICE. ETHNICITY- AFRICAN AMERICAN (B)(6)2009: HSG - NO RESULT PROVIDED. CONCURRENT CONDITIONS INCLUDED ABORTION, OBESITY, HYPERTENSION, DEPRESSION, BACTERIAL VAGINOSIS, HEADACHE, NABOTHIAN CYST, VAGINAL DISCHARGE, INFECTION, OVARIAN CYST AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6)2015 TO(B)(6)2015 AND NORETHISTERONE (MICRONOR) FROM (B)(6)2009 TO (B)(6)2009 FOR CONTRACEPTION AS WELL AS HYDROCHLOROTHIAZIDE;TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), IRON, LABETALOL, METHYLDOPA AND NIFEDIPINE (PROCARDIA). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN IN SIDES"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED, TO REMOVE THE ESSURE, BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED AND UNDERWENT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE DISLOCATION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 8, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD EMERGENCY C-SECTION DUE TO THE UMBILICAL CORD WRAPPED AROUND HIS NECK. TWO ABORTIONS AFTER ESSURE PLACEMENT. REMOVAL DETAILS:THE RIGHT ESSURE COIL WAS EMBEDDED IN THE RIGHT MYOMETRIUM JUST LATERAL TO THE RIGHT OSTIA. THIS WAS ALSO REMOVED HYSTEROSCOPICALLY. BOTH ESSURE COILS WERE REMOVED INTACT WITH NO PIECES LEFT BEHIND. THE PLAINTIFF EXPERIENCED TWO PREVIOUS PREGNANCY EPISODES CAPTURED UNDER THE CASES (B)(4) AND (B)(4). PATIENT EXPERIENCED ANOTHER TWO EPISODE OF PREGNANCY WHICH CAPTURED UNDER CASE(B)(4) AND (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(4)2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: RIGHT SIDE PAIN". CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(4)2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT ON (B)(4)2019: NO NEW INFORMATION ADDED.FU 12 AND FU 13 PROCESSED TOGETHER. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / PELVIC PAIN RIGHT SIDE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), EMBEDDED DEVICE ("LEFT DEVICE FOUND TO BE EMBEDDED IN THE UTERINE WALL"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 832032-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE// FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S),". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 (B)(6)1997,(B)(6)2002,(B)(6)2009,(B)(6)2015.), ECTOPIC PREGNANCY IN 2001, UMBILICAL CORD AROUND NECK, MENARCHE (AT THE AGE OF 13) AND PREGNANCY WITH CONTRACEPTIVE DEVICE. ETHNICITY- AFRICAN AMERICAN (B)(6)2009: HSG - NO RESULT PROVIDED. CONCURRENT CONDITIONS INCLUDED ABORTION, OBESITY, HYPERTENSION, DEPRESSION, BACTERIAL VAGINOSIS, HEADACHE, NABOTHIAN CYST, VAGINAL DISCHARGE, INFECTION AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6)2015 TO (B)(6)2015 AND NORETHISTERONE (MICRONOR) FROM (B)(6)2009 TO (B)(6)2009 FOR CONTRACEPTION AS WELL AS HYDROCHLOROTHIAZIDE;TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), IRON, LABETALOL, METHYLDOPA AND NIFEDIPINE (PROCARDIA XL). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN IN SIDES"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED, TO REMOVE THE ESSURE, BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED AND UNDERWENT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE DISLOCATION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 8, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD EMERGENCY C-SECTION DUE TO THE UMBILICAL CORD WRAPPED AROUND HIS NECK. TWO ABORTIONS AFTER ESSURE PLACEMENT. REMOVAL DETAILS:THE RIGHT ESSURE COIL WAS EMBEDDED IN THE RIGHT MYOMETRIUM JUST LATERAL TO THE RIGHT OSTIA. THIS WAS ALSO REMOVED HYSTEROSCOPICALLY. BOTH ESSURE COILS WERE REMOVED INTACT WITH NO PIECES LEFT BEHIND. THE PLAINTIFF EXPERIENCED TWO PREVIOUS PREGNANCY EPISODES CAPTURED UNDER THE CASES (B)(4). PATIENT EXPERIENCED ANOTHER TWO EPISODE OF PREGNANCY WHICH CAPTURED UNDER CASE(B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6)2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: RIGHT SIDE PAIN". CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2018: EVENT "MIGRATION OF ESSURE DEVICE" ADDED, PREVIOUSLY REPORTED EVENT "PAIN / PELVIC PAIN RIGHT SIDE " OUTCOME UPDATED TO "RECOVERED / RESOLVED" FROM PFS. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / PELVIC PAIN RIGHT SIDE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), EMBEDDED DEVICE ("LEFT DEVICE FOUND TO BE EMBEDDED IN THE UTERINE WALL") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT (GRAVIDA 8, PARA 4) WHO HAD ESSURE (BATCH NO. 832032-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE// FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S),". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6) 1997, (B)(6) 2002, (B)(6) 2009, (B)(6) 2015.), ECTOPIC PREGNANCY IN 2001, UMBILICAL CORD AROUND NECK AND MENARCHE (AT THE AGE OF 13). ETHNICITY- AFRICAN AMERICAN. CONCURRENT CONDITIONS INCLUDED ABORTION, OBESITY, HYPERTENSION, DEPRESSION, BACTERIAL VAGINOSIS, HEADACHE, NABOTHIAN CYST, VAGINAL DISCHARGE, INFECTION AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO (B)(6) 2015 AND NORETHISTERONE (MICRONOR) FROM (B)(6) 2009 TO (B)(6) 2009 FOR CONTRACEPTION AS WELL AS DYAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), IRON, LABETALOL, METHYLDOPA AND NIFEDIPINE (PROCARDIA XL). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN IN SIDES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE), SURGERY (TO REMOVE THE ESSURE, BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED) AND SURGERY (BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD EMERGENCY C-SECTION DUE TO THE UMBILICAL CORD WRAPPED AROUND HIS NECK. TWO ABORTIONS AFTER ESSURE PLACEMENT. REMOVAL DETAILS:THE RIGHT ESSURE COIL WAS EMBEDDED IN THE RIGHT MYOMETRIUM JUST LATERAL TO THE RIGHT OSTIA. THIS WAS ALSO REMOVED HYSTEROSCOPICALLY. BOTH ESSURE COILS WERE REMOVED INTACT WITH NO PIECES LEFT BEHIND. PATIENT EXPERIENCED ANOTHER TWO EPISODE OF PREGNANCY WHICH CAPTURED UNDER CASE-(B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: RIGHT SIDE PAIN". CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-OCT-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN / PELVIC PAIN RIGHT SIDE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S))"), EMBEDDED DEVICE ("LEFT DEVICE FOUND TO BE EMBEDDED IN THE UTERINE WALL"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 832032-INVALID, 632032) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE// FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S),". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6) 1997,(B)(6) 2002,(B)(6) 2009,(B)(6) 2015.), ECTOPIC PREGNANCY IN (B)(6) , UMBILICAL CORD AROUND NECK, MENARCHE (AT THE AGE OF 13) AND PREGNANCY WITH CONTRACEPTIVE DEVICE. ETHNICITY- AFRICAN AMERICAN. ON (B)(6) 2009: HSG - NO RESULT PROVIDED. CONCURRENT CONDITIONS INCLUDED ABORTION, OBESITY, HYPERTENSION, DEPRESSION, BACTERIAL VAGINOSIS, HEADACHE, NABOTHIAN CYST, VAGINAL DISCHARGE, INFECTION, OVARIAN CYST AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO (B)(6) 2015 AND NORETHISTERONE (MICRONOR) FROM (B)(6) 2009 TO (B)(6) 2009 FOR CONTRACEPTION AS WELL AS HYDROCHLOROTHIAZIDE;TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), IRON, LABETALOL, METHYLDOPA AND NIFEDIPINE (PROCARDIA). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) , THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN IN SIDES"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED, TO REMOVE THE ESSURE, BILATERAL TUBAL LIGATION WITH ESSURE REMOVAL/FALLOPIAN TUBE REMOVED AND UNDERWENT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE DISLOCATION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 8, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD EMERGENCY C-SECTION DUE TO THE UMBILICAL CORD WRAPPED AROUND HIS NECK. TWO ABORTIONS AFTER ESSURE PLACEMENT. REMOVAL DETAILS:THE RIGHT ESSURE COIL WAS EMBEDDED IN THE RIGHT MYOMETRIUM JUST LATERAL TO THE RIGHT OSTIA. THIS WAS ALSO REMOVED HYSTEROSCOPICALLY. BOTH ESSURE COILS WERE REMOVED INTACT WITH NO PIECES LEFT BEHIND. THE PLAINTIFF EXPERIENCED TWO PREVIOUS PREGNANCY EPISODES CAPTURED UNDER THE CASES (B)(4) ((B)(6)) AND (B)(4) ((B)(6)). PATIENT EXPERIENCED ANOTHER TWO EPISODE OF PREGNANCY WHICH CAPTURED UNDER CASE-(B)(4) AND (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: RIGHT SIDE PAIN". CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JAN-2019: MEDICAL RECORD WAS RECEIVED. LOT NUMBER, REPORTER INFORMATION, MEDICAL HISTORY WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN ("PAIN IN SIDES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2015. T THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: THIS CASE WAS CONVERTED FROM THE CONCEPTUS DATABASE INTO (B)(4) ON (B)(6) 2014 AND IT WAS INITIALLY REPORTED BY A CONSUMER. FURTHER INFORMATION (LEGAL CLAIM) WAS RECEIVED ON (B)(6) 2017 AND QUALIFIES THIS PREVIOUS CONCEPTUS CASE AS REPORTABLE CASE BY BAYER: LAWYERS WERE ADDED. EVENTS ADDED: PAIN IN SIDES AND PAIN. ESSURE WAS REMOVED ON (B)(6) 2015 BY SURGERY. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836346 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 832032-INVALID, 632032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| IRON| IRON| IRON| IRON| IRON| LABETALOL| LABETALOL| LABETALOL| LABETALOL| LABETALOL| METHYLDOPA| METHYLDOPA| METHYLDOPA| METHYLDOPA| METHYLDOPA| MICRONOR| MICRONOR| MICRONOR| MICRONOR| MICRONOR| PROCARDIA XL| PROCARDIA XL| PROCARDIA XL| PROCARDIA [NIFEDIPINE]| PROCARDIA [NIFEDIPINE]| TRIAMTERENE| TRIAMTERENE AND HYDROCHLOROTHIAZIDE| TRIAMTERENE AND HYDROCHLOROTHIAZIDE| TRIAMTERENE AND HYDROCHLOROTHIAZIDE| TRIAMTERENE AND HYDROCHLOROTHIAZIDE |